Benazepril Hydrochloride

Product NDC
10544-561
11-digit product format
105440561
Labeler code
10544
Product ID
10544-561_4d8f36dc-b1c3-42dc-aae7-bc8c18db7073
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA076118
Marketing category
ANDA
Marketing start
2013-11-13
Marketing end
0000-00-00
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10544-561IInactivated by FDA2026-08-17
excluded packagepackage10544-56110544-561-30IInactivated by FDA2026-08-17
excluded packagepackage10544-56110544-561-90IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-561-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-561-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-561-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-561-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-561-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-561-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-561-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-561-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-561-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-561-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-561-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-561-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-561-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-561-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-561-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-561-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-561-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-561-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10544-561-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10544-561-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10544-561-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10544-561-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10544-561-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10544-561-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10544-561-908af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10544-561-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10544-561-90834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10544-561-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10544-561-901332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10544-561-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10544-561-90fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10544-561-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10544-561-9086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10544-561-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10544-561-90bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10544-561-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10544-561-908dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10544-561-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10544-561-90e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10544-561-30e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076118-001BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11
A076118-002BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11
A076118-003BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11
A076118-004BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076118-001AB
A076118-002AB
A076118-003AB
A076118-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076118-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076118-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076118-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-004AB1d8e5a09893c0…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-561-302020-01-31C16284748780-19d75b9cf-f6bc-f424-e053-dadaa90a57ce14db4981-5e50-4551-84f0-24f2c833d629
10544-561-902020-01-31C16284748780-19d75b9cf-f6bc-f424-e053-dadaa90a57ce14db4981-5e50-4551-84f0-24f2c833d629

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-561-30Benazepril Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
10544-561-90Benazepril Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-561BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20151023_14db4981-5e50-4551-84f0-24f2c833d629.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.afd616b9-0c75-48be-862d-5ac18364fd9d2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.01a3c9f6-41aa-47a7-8c56-5462c6b544162026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.032ea0f7-3304-4778-b3a6-6125ea7537ab2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutions7aac6a2f-85fb-4c7a-b424-9c253186dffe2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC3631d1dc-45e1-0588-e054-00144ff88e882026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC708110e5-fa45-44e0-9011-261f4490ea452026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC471cd30a-401a-c8f9-e063-6294a90a47872025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutions6c24bb4c-42d2-483a-b33f-95182b32b93d2025-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutions8f46e2c9-9b3b-48d0-a307-9069e38799592025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEGolden State Medical Supply, Inc.cb93e793-fe4f-452c-e053-2995a90a73332025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a7b373a-9b74-4b9d-93fb-081614222e302025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.355811f0-2885-0d49-e054-00144ff8d46c2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.55c99902-3d4d-05e9-e054-00144ff8d46c2025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.4d5a8b50-dd2f-4329-9e28-93608e8fe8da2025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDEDIRECT RXa7e4e43a-7abc-e2a5-e053-2995a90ab5f42025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack08bc0034-3b33-47d8-aec2-b36535ac85a22024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack0653322d-70c6-45f7-a9d1-41efee1d73872024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.7274fdaf-1247-2b2f-e053-2991aa0ad3f62024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.700c828c-86c6-1857-e053-2a91aa0ae3142024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.9535ec77-2d50-4817-e053-2995a90a007e2024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898719benazepril HCl 40 MG Oral TabletPSN14db4981-5e50-4551-84f0-24f2c833d6291
898719benazepril hydrochloride 40 MG Oral TabletSCD14db4981-5e50-4551-84f0-24f2c833d6291
898719BZP hydrochloride 40 MG Oral TabletSY14db4981-5e50-4551-84f0-24f2c833d6291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-561-301054405613030 in 1 BOTTLEHistorical
10544-561-901054405619090 in 1 BOTTLEHistorical